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  1. TDA
    11,411 Posts.
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    29/09/10
    09:01
    Post #: 7255600
    ANDA Filing:

    All sections have been reviewed
    - Chemistry, Manufacturing and Controls (CMC)
    - Labeling
    - Microbiology
    - Bioequivalence
    - Other (Packaging, Device)
    - Average approval times for generics now >27months*
    - Priority approval times ~13months (+/-3m) after acceptance**
    - Several generics approved in recent months with similar/later ANDA #s
    ACL Price at posting: 47.0¢ Sentiment: Buy Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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